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RECRUITING

NCT04192773

EARLY_PHASE1

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

Sponsor: D. Bradley Welling, MD, PhD

View on ClinicalTrials.gov

Summary

This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary suppression of the tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-04-28

Completion Date

2027-12-31

Last Updated

2025-12-02

Healthy Volunteers

Yes

Conditions

Tinnitus

Interventions

DRUG

IV Lidocaine

IV lidocaine will be administered pre-fMRI and post-FMRI with each subject acting as their own control

Inclusion Criteria: -Age ≥ 18 * Ability to provide informed consent * English speaker * Falls under one of the four groups a. Normal Hearing without Tinnitus (NH/T-) i. Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective confirmation of lack of tinnitus\* 1. Never or rarely b. Normal Hearing with Tinnitus (NH/T+) i. Normal Hearing Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective confirmation of tinnitus\* 1. Often, always c. Unilateral hearing loss and ipsilateral unilateral tinnitus (uHL/uT+) i. Unilateral hearing loss as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in the bad ear and 25 dB or less in good ear ii. Subjective confirmation of tinnitus in the good ear\* 1. Often, always d. Bilateral hearing loss and bilateral tinnitus (bHL/bT+) i. Bilateral hearing loss as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in both ears ii. Subjective confirmation of tinnitus in both ears\* 1. Often, always * Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always Exclusion Criteria: * Currently undergoing tinnitus treatment with other pharmacologic agents a. Patients may be eligible if they complete a 60 day washout period from pharmacologic agents treating tinnitus * Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot be removed. * Contraindications to IV lidocaine administration such known allergy to lidocaine * History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker * History of seizure disorder * Resting BP of \<100/50 * Currently taking antiarrhythmics * Have taken antibiotics within 48 hours of infusion * Known hepatic failure * Pregnant or lactating women * Patient with other neurological or psychiatric disorders, such as stroke, brain tumor, schizophrenia, bipolar disorder. * Patients who cannot fill out the questionnaires

Locations (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States